Drugs / Ubrogepant
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed migraine disorder 1 milestone | |||||
| Filed | US (FDA) | — | migraine disorder | 2019-03-11 | “the U.S. Food and Drug Administration ( FDA ) has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults.” abbvie.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | UBRELVY | — | 2019-12-23 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07680686 | Jun → Oct 2026 expected | — | AbbVie | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT04818515 | Mar → Jun 2021 | migraine disorder | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT04179474 | Sep → Dec 2019 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 37 trials · 2 met primary | ||||||
| Phase 3 | NCT06417775 | Sep 2024 → Jun 2027 expected | migraine disorder | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05127954 | Jan 2022 → Jan 2028 expected | migraine disorder | AbbVie | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05125302 | Jan 2022 → May 2027 expected | migraine disorder | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT04492020 | Aug 2020 → Apr 2022 | migraine disorder | AbbVie | Completed | Met primary |
| Phase 3 | NCT02873221 | Sep 2016 → Aug 2018 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT02867709 | Aug 2016 → Jan 2018 | migraine disorder | Allergan | Completed | Mixed |
| Phase 3 | NCT02828020 | Jul 2016 → Dec 2017 | migraine disorder | Allergan | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT05264129 | Mar 2022 → Apr 2023 | migraine disorder | AbbVie | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05654298 | Mar 2022 → Mar 2023 | migraine disorder | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT06578585 Background | Sep 2024 → Jul 2025 | migraine disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT05892757 Comparator | Jul 2023 → Feb 2024 | — | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT05894954 Background | Jul 2023 → Oct 2025 | cognitive impairment with or without cerebellar ataxia, dementia | Alzheimer's Prevention and Reversal Project, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT05503082 Comparator | Sep 2022 → Sep 2024 overdue | migraine disorder | Chicago Headache Center & Research Institute | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05214001 Comparator | Jun 2022 → Apr 2024 | migraine with aura, migraine without aura | Messoud Ashina, MD | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2023-11-16 | AbbVie | Results Results Published in The Lancet Show UBRELVY® (ubrogepant) Reduces the Headache Phase of a Migraine Attack When Dosed During the Prodrome of Migraine abbvie.com ↗
AbbVie (NYSE: ABBV) today announced detailed results published in The Lancet evaluating the efficacy, safety, and tolerability of UBRELVY ® (ubrogepant) 100 mg for the acute treatment of migraine when administered during the prodrome of a migraine attack. |
| 2021-06-03 | Eli Lilly and Company | Results Lilly Reveals Critical Barriers to Optimal Migraine Care and Insights From Novel Clinical and Patient-Centric Real-World Evidence, Supporting Lilly's Preventive and Acute Treatment Portfolio at AHS 2021 lilly.com ↗
people taking 100 mg and 200 mg doses of REYVOW® (lasmiditan) C-V had greater odds of early onset of efficacy compared to those taking Nurtec® (rimegepant) or UBRELVY® (ubrogepant). |
| 2020-06-15 | AbbVie | Results AbbVie to Showcase 27 Studies at the Virtual 2020 Annual Scientific Meeting of the American Headache Society abbvie.com ↗
An analysis of 2246 participants from the ACHIEVE trials demonstrated that concomitant preventive medication use did not impact the efficacy of UBRELVY™ for the acute treatment of migraine, and no safety signal was identified with concomitant use. |
| 2019-12-04 | AbbVie | Results Allergan Announces Positive Phase 3 ACHIEVE I Trial Results for Ubrogepant Published in The New England Journal of Medicine abbvie.com ↗ |
| 2019-11-19 | AbbVie | Results Allergan Announces Positive Phase 3 ACHIEVE II Trial Results for Ubrogepant Published in The Journal of the American Medical Association abbvie.com ↗
Pivotal Phase 3 clinical trial reinforced efficacy, safety and tolerability of ubrogepant, an orally-administered CGRP receptor antagonist (gepant) |
| 2019-07-09 | AbbVie | Results Allergan Continues to Demonstrate Leadership in Migraine with 29 Presentations at the 2019 American Headache Society Annual Meeting abbvie.com ↗
Ubrogepant Achieves Early Pain Relief for the Acute Treatment of Migraine. |
| 2019-05-02 | AbbVie | Results Allergan Continues to Display Leadership in Neurosciences with 29 Presentations at 2019 American Academy of Neurology Annual Meeting abbvie.com ↗
Improved Functionality, Pain Relief, and Satisfaction in Patients Treated with Ubrogepant vs Placebo: Results from 2 Single-Attack Phase 3 Studies, ACHIEVE I and II |
| 2019-03-11 | AbbVie | Regulatory Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine abbvie.com ↗
Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration ( FDA ) has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults. |
| 2018-10-17 | AbbVie | Results Allergan Announces Completion of Two Positive Safety Studies for Ubrogepant - an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine abbvie.com ↗
Allergan plc (NYSE: AGN) today announced the completion of two positive safety and tolerability studies of ubrogepant for the acute treatment of migraine. |
| 2018-04-27 | AbbVie | Results Allergan Announces Second Positive Phase 3 Clinical Trial for Ubrogepant -- an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine abbvie.com ↗ |
| 2018-02-06 | AbbVie | Results Allergan Announces Positive Top Line Phase 3 Results for Ubrogepant - an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine abbvie.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ubrogepant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06578585 ↗ |
| Known as | Ubrelvy | “Ubrogepant (Ubrelvy), a CGRP receptor antagonist, is approved for acute treatment of migraine with or without aura in adults.” PMID 42012062 ↗ Apr 20262“Vascular treatments may include: antihypertensives, Ubrelvy, aspirin, Eliquis” NCT05894954 ↗ “Ubrogepant 50 MG [Ubrelvy]” NCT05503082 ↗ |
| Action | Inhibit | “Ubrogepant is an oral, small-molecule calcitonin gene-related peptide receptor antagonist for acute migraine treatment.” PMID 31800988 ↗ Dec 2019 |
| Modality | Small molecule | “Ubrogepant is an oral, small-molecule calcitonin gene-related peptide receptor antagonist for acute migraine treatment.” PMID 31800988 ↗ Dec 2019 |
| Route | Oral | “50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.” NCT02828020 ↗ |